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Allergy Testing (L31270) RETIRED

LCD - Local Coverage Determination

Medicare Policies and Guildelines

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LCD

Indications and Limitations of Coverage and/or Medical Necessity

Allergy is a form of exaggerated sensitivity or hypersensitivity to a substance that is either inhaled, ingested, injected, or comes in contact with the skin or eye. The term allergy is used to describe situations where hypersensitivity results from heightened or altered reactivity of the immune system in response to external substances. Allergic or hypersensitivity disorders may be manifested by generalized systemic reactions as well as localized reactions in any part of the body. The reactions may be acute, subacute, or chronic, immediate or delayed, and may be caused by a variety of offending agents; pollen, molds, mites, dust, feathers, animal fur or dander, venoms, foods, drugs, etc.

Allergy testing is performed to determine a patient's immunologic sensitivity or reaction to particular allergens for the purpose of identifying the cause of the allergic state, and is based on findings during a complete medical and immunologic history and appropriate physical exam obtained by face-to-face contact with the patient.

Allergy testing can be broadly subdivided into two methodologies:

A. In vivo testing (skin tests): this testing correlates the performance and evaluation of selective cutaneous and mucous membrane tests with the patient's history, physician examination, and other observations.

Patients at increased risk for anaphylactic response from skin testing based on clinical history (e.g., when an unusual allergen is not available as a licensed skin test extract), or who have a history of a previous systemic reaction to skin testing.

Patients in whom skin testing was equivocal/inconclusive and in vitro testing is required as a confirmatory test.

Limitations

FCSO Medicare does not cover in vitro allergy testing for the following, because it is considered not medically reasonable and necessary:

Patients with no contraindications to skin testing

Patients being treated successfully for allergies

Patients with mild symptoms

Patients who have had negative skin testing for the allergy in question

In vitro testing is covered when medically reasonable and necessary as a substitute for skin testing; it is not usually necessary in addition to skin testing.

Qualitative multi-allergen screen (CPT code 86005) is a non-specific screening test that does not identify a specific antigen, and is not covered.

The use of sublingual, intracutaneous, and subcutaneous provocative and neutralization testing and neutralization therapy for food allergies are excluded from Medicare coverage because available evidence does not show that these tests and therapies are effective (CMS Manual System, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Section 110.11).

Allergen-specific IgG and IgG subclasses measured by using immunoabsorption assays and IgG and IgG subclass antibody tests for food allergy/delayed food allergic symptoms or intolerance to specific foods (eg., CPT code 86001) are considered experimental and investigational, as there is insufficient evidence in the published peer-reviewed scientific literature to support the diagnostic value of these tests.

The following tests are considered experimental and investigational for allergy testing as they have not been proven to be effective. These tests are not appropriate for the evaluation and/or management of IgE-mediated allergic reactions.

Testing of total serum IgG, immunoglobulin A (IgA) and immunoglobulin M (IgM)

Prausnitz-Kustner or P-K testing - passive cutaneous transfer test

Pulse test (pulse response test, reaginic pulse test)

Rebuck skin window test

Sage Complement Antigen Test

Measurements of total IgE levels (CPT code 82785-Gammaglobulin[immunoglobulin]; IgE) are not appropriate in most general allergy testing which is performed to determine a patient's immunologic sensitivity or reaction to particular allergens for the purpose of identifying the cause of the allergic state. It would not be expected that total serum IgE levels would be billed unless evidence exists for allergic bronchopulmonary Asperigillosis (ABPA), select immunodeficiencies, such as the syndrome of hyper-IgE, eczematous dermatitis, atopic dermatitis in children and recurrent pyogenic infections, or in the evaluation for omalizumab therapy. Serial, repeat testing of total IgE will be subject to medical review.

CMS National Coverage Policy:

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources:

The interpretation of the test results and how the results of the test will be used in the patient's plan of care.

Per 42 CFR §410.32, all diagnostic tests must be ordered by the physician/nonphysician practitioner who is treating the patient, that is, the physician/nonphysician practitioner who furnishes a consultation or treats a patient for a specific medical problem and who uses the results in the management of the patient's specific medical problem. Tests not ordered by the physician/nonphysician practitioner who is treating the patient are not reasonable and necessary.

Providers should not submit additional information with the claim. FCSO Medicare may request it separately with an additional documentation request (ADR) letter.

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Utilization Guidelines

It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

It would not be expected that all patients would receive the same tests or the same number of sensitivity tests. The number of tests performed must be judicious and related to the history, physical findings and clinical judgment specific to each individual patient.

In vitro testing is covered when medically reasonable and necessary as a substitute for skin testing; it is not usually necessary in addition to skin testing.

In vitro testing (CPT code 86003) will be covered for only thirty (30) units per year for medically reasonable and necessary indications as outlined in this LCD. Services exceeding this parameter will be considered not medically necessary.

It would not be expected that more than twenty (20) units be reported for percutaneous testing per year for food sensitivity (CPT code 95004).

It would not be expected that more than forty (40) units be reported for intracutaneous (intradermal) testing (CPT code 95024) per year for a patient.

It would not be expected that more than forty (40) units be reported for intracutaneous (intradermal), sequential and incremental testing (CPT code 95027) per year for a patient.

When photo patch test(s) (CPT code 95052) are performed (same antigen/same session) with patch or application test(s) (CPT code 95044), only the photo patch tests should be reported.

In the event photo tests (CPT code 95056) are performed with patch or application test(s) (CPT code 95044), only the photo tests should be reported.

Start Date of Comment Period:

End Date of Comment Period:

Start Date of Notice Period:

Sources of Information and Basis for Decision

Contact dermatitis: a practice parameter. (2006). The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI), 100, S1-S38.

Food allergy: a practice parameter. (2006). The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI), 96, S1-S68.

Other Contractor(s) LCDs

Practice parameters for allergy diagnostic testing: An updated practice parameter. (2008). The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI), 100(3), S1-S148. Retrieved on August 31, 2009 from http://www.acaai.org/Member/PracticeParam/default.htm.

U.S. Department of Health and Human Services. (2008) National asthma education and prevention program guidelines implementation panel report 3-Guidelines for the diagnosis and management of asthma, (NIH Publication No. 09-6147), 1-44 (Retrieved on November 10, 2009 from http://www.nhlbi.nih.gov/guidelines/asthma/gip_rpt.htm on November 10.

Advisory Committee Meeting Notes

This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Appendicies:

Not Specified.

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Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.
Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill
Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.